title: Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia.
abstract: OBJECTIVE
  To determine the effectiveness of a melatonin agonist for treating sleep disturbances in individuals with tetraplegia.
  
  
  METHODS
  Placebo-controlled, double-blind, crossover, randomized control trial.
  
  
  METHODS
  At home.
  
  
  METHODS
  Eight individuals with tetraplegia, having an absence of endogenous melatonin production and the presence of a sleep disorder. Interventions Three weeks of 8 mg of ramelteon (melatonin agonist) and 3 weeks of placebo (crossover, randomized order) with 2 weeks of baseline prior to and 2 weeks of washout between active conditions.
  
  
  RESULTS
  Change in objective and subjective sleep.
  
  
  METHODS
  Wrist actigraphy, post-sleep questionnaire, Stanford sleepiness scale, SF-36.
  
  
  RESULTS
  We observed no consistent changes in either subjective or objective measures of sleep, including subjective sleep latency (P = 0.55, Friedman test), number of awakenings (P = 0.17, Friedman test), subjective total sleep time (P = 0.45, Friedman test), subjective morning alertness (P = 0.35, Friedman test), objective wake after sleep onset (P = 0.70, Friedman test), or objective sleep efficiency (P = 0.78, Friedman test). There were significant increases in both objective total sleep time (P < 0.05, Friedman test), subjective time in bed (P < 0.05, Friedman test), and subjective sleep quality (P < 0.05, Friedman test), although these occurred in both arms. There were no significant changes in any of the nine SF-36 subscale scores (Friedman test, Ps >Bonferroni adjusted α of 0.005).
  
  
  CONCLUSIONS
  In this pilot study, we were unable to show effectiveness of pharmacological replacement of melatonin for the treatment of self-reported sleep problems in individuals with tetraplegia. Trial Registration ClinicalTrials.gov # NCT00507546.
authors.forename: Jamie M
authors.initials: JM
authors.lastname: Zeitzer
authors.forename: Ban
authors.initials: B
authors.lastname: Ku
authors.forename: Doug
authors.initials: D
authors.lastname: Ota
authors.forename: B Jenny
authors.initials: BJ
authors.lastname: Kiratli
mesh_terms: D000975:Antioxidants / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D011782:Quadriplegia / Q000150:complications*; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology*; D011795:Surveys and Questionnaires
chemical_list: D000975:Antioxidants; D008550:Melatonin
keywords: Melatonin; Randomized control trial; Sleep; Sleep initiation and maintenance disorders; Spinal cord injuries; Tetraplegia